GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements

Scope

This document specifies the general requirements for biological indicators (including contaminated carriers and test bacterial suspensions) and other components intended for use in confirming and monitoring sterilization cycles in terms of production, labeling, testing methods, and performance.
The basic requirements of this document apply to all parts of GB/T 18281. The requirements for biological indicators used in specific sterilization processes are specified in the relevant sections of GB/T 18281. This document applies to biological indicators that do not have special requirements.
Note: Regulations of some countries or regions may apply.
This document does not apply to testing systems that rely on physical methods to remove microorganisms, such as filtration processes or processes that use physical and/or mechanical methods like cleaning and disinfecting devices or circulating steam to inactivate microorganisms. However, this document may include content related to corresponding microbial testing systems.

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